Production Operator II

Key Responsibilities

• Work with Production Supervisor and Management team to improve the process
• Collaborate with the shift supervisor to ensure the shift is running efficiently while leading by example
• Collaborate with the shift supervisor to train other members of the team
• Write and review relevant SOPs
• Help ensure the site is in an audit ready state
• Perform routine cleaning/disinfection of the cleanroom suites
• Complete: reading SOPs, gowning qualification, media fills, process training, bioburden runs, PV runs, tech transfer
• Follow daily routine production
• Follow EHS regulations/guidelines: NRC (ALARA), OSHA, EPA, chemical, waste disposal, state/local regulations, etc.
• Manufacturing activities following SOPs, using proper aseptic technique
• Setup production; line clearance; clean/VPHP
• Troubleshoot urgent problems
• Identify, document, communicate failures/near misses
• Quality/continuous improvement: Adhere to SOPs, company policies, regulatory requirements, laws
• Work closely with QC/QA to deliver quality products
• Assist with deviations, OOT/OOS, CAPAs, change controls, audits, inspections
• Cross-train and perform: Cleanrooms: cleaning, EM, restocking Routine radiation surveys, wipe tests
• Maintain paper/electronic batch records, equipment logs, other records
• Equipment: maintain, qualify, calibrate, prepare, report problems, troubleshooting
• Maintain stock of materials/supplies; obtain documentation for raw material release
• Mentor new employees
• Train new employees
• Other tasks as needed

Qualifications

• Education: Associate’s degree or equivalent (60 college credit hours) with 2+ years of relevant experience, or High School Diploma (or equivalent) with 3 or more years of experience in a quality or production-related role within a GMP environment.
• Experience: Hands-on GMP production of sterile pharmaceuticals 2+ yrs Cleanroom operations: gowning, cleaning, EM, aseptic technique Follow detailed SOPs, complete detailed documentation (e.g., batch records) QMS in a regulated environment: QA, GDP, SOPs, document control, change control Owns the manufacturing process; work well in a fast-paced, high-pressure environment with tight deadlines Attention to detail; meticulous execution/documentation Attendance: dependable, on time; flexible for variable schedule Work well under direct supervision or independently Time management